BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCK

    MDR report key: 3807954 · Received February 7, 2014

    Report

    Report Number
    9610816-2014-00028
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Report Date
    January 8, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    CCK
    PMA / PMN Number
    K011536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BONDING OF THE M2520A SMART CAPNOLINE WAS NOT SECURE AND THAT PLASTIC PARTS COULD SEPARATE AND ENTER INTO THE PTS' MOUNT. NO PT INCIDENT/INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81012 CCK SMART CAPNOLINE O2, PEDIATRRIC CCK PHILIPS MEDICAL SYSTEMS M2520A LOT Q 120807

    Patients

    Seq Age Sex Outcome Treatment
    1